cetrorelix (injectable)

cetrorelix (injectable)

What is the most important information I should know about cetrorelix?

Do not use cetrorelix if you are pregnant. Cetrorelix is in the FDA pregnancy category X. This means that cetrorelix is known to cause birth defects.

Talk to your doctor before using cetrorelix if you have kidney disease or any renal (kidney) problems. Cetrorelix should not be used in patients with severe renal impairment.

What is cetrorelix?

Cetrorelix blocks the effects of the naturally occurring gonadotropin-releasing hormone (GnRH). GnRH controls the release of another hormone, luteinizing hormone (LH), which induces ovulation (release of an egg from the ovary) during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix blocks this undesirable premature ovulation.

Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation.

Cetrorelix may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using cetrorelix?

Do not use cetrorelix without first talking to your doctor if you have ever had an allergic reaction to gonadotropin-releasing hormone (Lupron, Antagon, Goserelin, Naferelin, Synarel, Zoladex), mannitol, or a medicine similar to cetrorelix.

Do not use cetrorelix if you are pregnant. Cetrorelix is in the FDA pregnancy category X. This means that cetrorelix is known to cause birth defects.

It is not known whether cetrorelix passes into breast milk. Do not use cetrorelix without first talking to your doctor if you are breast-feeding a baby.

Talk to your doctor before using cetrorelix if you have kidney disease or any renal (kidney) problems. Cetrorelix should not be used in patients with severe renal impairment.

How should I use cetrorelix?

Use cetrorelix exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Cetrorelix is intended for subcutaneous (under the skin) administration. If you are administering this medication at home, your doctor will give you detailed instructions on how to mix the solution and administer the injection. Do not inject cetrorelix if you are not sure how.

Cetrorelix may be prescribed for use as a single dose (3 mg), or for use once a day (0.25 mg). Your doctor will determine which treatment regimen is best for you. Follow your doctor's instructions.

Wash your hands well with soap and water before preparing and administering this medication.

To prepare the injection:

On a clean surface, lay out everything that you need. Flip off the plastic cover of the vial. Wipe the aluminum ring and the rubber stopper with an alcohol wipe. Take the injection needle with the yellow mark and remove the wrapping. Take the pre-filled syringe (filled with sterile water for injection) and remove the cover. Put the needle on the pre-filled syringe and remove the cover. Push the needle through the center of the rubber stopper of the vial. Inject the water into the vial by slowly pushing the plunger of the syringe. Leave the syringe on the vial. Gently shake the vial until the solution is clear and without residue. Avoid forming bubbles during dissolution.

Withdraw the entire contents of the vial into the syringe. If liquid is left in the vial, invert the vial, pull back the needle until the opening of the needle is just inside the stopper. If you look from the side through the gap in the stopper, you can control the movement of the needle and the liquid. It is important to withdraw the entire contents of the vial. Detach the syringe from the needle and lay down the syringe.

Take the injection needle with the grey mark and remove its wrapping. Put the needle on the syringe and remove the cover of the needle. Invert the syringe and push the plunger until all air bubbles have been pushed out. Do not touch the needle or allow the needle to touch any surface.

To administer the injection:

Choose an injection site at the lower abdominal wall, preferably around the belly button. If you are on a multiple dose (0.25 mg) regimen, choose a different injection site each day to minimize local irritation. Take the second alcohol wipe and clean the skin at the injection site. Inject the prescribed dose as directed by your doctor or healthcare provider.

Use the solution immediately after it is mixed. Throw away any medicine that is left over.

Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.

Store the 3 mg cetrorelix product at room temperature, away from direct light, moisture, and heat. Keep the packaged tray in the outer carton to protect it from light.

Store the 0.25 mg cetrorelix product in the refrigerator in the original outer carton , to protect it from light and moisture.

What happens if I miss a dose?

Contact your doctor if you miss a dose of cetrorelix. Do not use a double dose of this medication without first talking to your doctor.

What happens if I overdose?

An overdose of cetrorelix is unlikely to threaten life. If an overdose of cetrorelix is suspected, notify your doctor immediately to check whether an adjustment of the further ovarian stimulation procedure is required. If you cannot contact your doctor, call an emergency room or poison control center for advice.

What should I avoid while using cetrorelix?

There are no restrictions on food, beverages, or activity during therapy with cetrorelix unless otherwise directed by your doctor.

What are the possible side effects of cetrorelix?

Stop using cetrorelix and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Approximately 3.5 % of female patients treated with cetrorelix have developed ovarian hyperstimulation syndrome (OHSS). Symptoms of OHSS include severe pelvic pain, swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these symptoms.

Other side effects may also occur. Notify your doctor if you experience

nausea;

headache; or

redness, bruising, itching, or swelling at the injection site.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect cetrorelix?

It is not known whether other medications will interact with cetrorelix. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

Your pharmacist can provide more information about cetrorelix.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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